New longer-term data reinforce safety of Roche’s satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder - Seite 2

The safety profile of satralizumab in the open-label extension (OLE) was consistent with the double-blind period with respect to the nature and rate of AEs. There were no meaningful changes in incidence, rate, or type of infections.

In a separate analysis from the SAkuraSky study, adolescents treated with satralizumab (n=8) with the same dosing and frequency demonstrated a benefit-risk profile generally consistent with the adult population. Data from the adolescent group found the range of model-predicted exposures was similar to those in adults when treated with the same adult dosing regimen, receiving placebo or satralizumab 120 mg in combination with baseline therapy at weeks 0, 2 and 4, and every four weeks thereafter.

“It is highly encouraging to see the positive results from the satralizumab trial in young people with NMOSD. There is no approved treatment option for this condition, and youngsters live day-to-day with the possibility of unpredictable, severe relapses that can cause life-long disability,” said Cheryl Hemingway, M.D., Ph.D., Great Ormond Street Children’s Hospital, London, UK. “The satralizumab studies represented a broad population, including adolescents, and we are hopeful for what this medicine could bring to young people living with this rare condition.”

Finally, in a third presentation based on pharmacokinetic and pharmacodynamics analyses from Phase I and the two pivotal Phase III studies, the dosing regimen of satralizumab, 120mg every four weeks, showed significant sustained IL-6 signalling inhibition. In the NMOSD population, the pharmacokinetics (PK) of satralizumab indicated that the 120mg dose allowed for more than 95% binding to the IL-6 receptor throughout the full 4-week dosage period.

About SAkuraStar and SAkuraSky in NMOSD
SAkuraStar is a Phase III multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab monotherapy administered to patients with NMOSD. The primary endpoint is the time to first protocol-defined relapse (PDR), adjudicated by an independent review committee in the double-blind period. Results from the SAkuraStar study were presented at the 35th  Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 11-13, 2019, and were published in The Lancet Neurology in April 2020.